Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis

What Was Tested

The trial (phase 1, phase 2) is built around Insulin (regular human) for multiple sclerosis.

Subjects will administer a sterile diluent containing inactive ingredients in the nostrils using a ViaNaseTM controlled particle dispersion nasal device two times/day (BID) for 24 weeks.

The registry classes the interventions as drug.

More on the Plan

Cognitive impairment is common in and devastating to people with MS.

MS is a common, chronic, central nervous system (CNS) disease characterized by inflammation, demyelination, and neurodegeneration.

Several cognitive domains are impacted in people with MS, including attention, memory, executive functioning, and especially processing speed.

Furthermore, cognitive rehabilitation is often time consuming, costly, and not universally available.

Who Took Part

Enrollment: 105 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Meets 2010 criteria for MS. No relapse in past 3 months. At least mild cognitive impairment (based off of SDMT/PST score). Capacity to learn and self-administer intranasal insulin/placebo, or presence of a caregiver with such capacity who is willing to do it for the duration of the trial. Untreated/on the same MS therapy for at least 6 months, with no anticipated change in the next year.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: current, active major depression; pregnant or nursing; THC; illicit drug or alcohol abuse in past 3 months.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-12-01 with completion listed for 2021-12-17.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Cognitive Function as Assessed by the Symbol Digit Modalities Test (SDMT) (time frame: Up to week 24 visit).

It also tracked 8 secondary outcomes, for example Number of Participants With Adverse Events Leading to Study Discontinuation, Fingerstick Blood Glucose (Subset), Change From Baseline in Cognitive Function as Assessed by the Controlled Oral Word Association Test (COWAT), Change From Baseline in Cognitive Function as Assessed by the California Verbal Learning Test, Second Edition (CVLT-II), Change From Baseline in Cognitive Function as Assessed by the Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall and Change in Cognitive Function as Assessed by the Rao-version of the Paced Auditory Serial Addition Test (PASAT).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Insulin (regular human) in 105 people with multiple sclerosis.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page, Multiple sclerosis research.